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CLARINEX-D® 12 HOUR (desloratadine and pseudoephedrine sulfate) Extended Release Tablets is indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis including nasal congestion, in adults and children 12 years of age and older. CLARINEX-D® 12 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant activity of pseudoephedrine are desired (see CLINICAL PHARMACOLOGY).
DOSAGE AND ADMINISTRATION
Adults and children 12 years of age and over: The recommended dose of CLARINEX-D®12 HOUR Extended Release Tablets is one tablet twice a day, administered approximately 12 hours apart and with or without a meal. CLARINEX-D®12 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment and patients with renal impairment.
CAUTION: Do not to break or chew the tablet; swallow whole.
CLARINEX-D®12 HOUR Extended Release Tablets contain 2.5 mg desloratadine in the blue immediate-release layer and 120 mg of pseudoephedrine sulfate, USP in the white extended-release layer. CLARINEX-D®12 HOUR Extended Release Tablets are oval shaped, blue and white bilayer tablets with “D12” embossed in the blue layer; supplied in high-density polyethylene bottles of 100 (NDC 0085-1322-01).
Protect from excessive moisture. Protect from light.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid exposure at or above 30°C (86°F).
Manufactured for Schering Corporation, Kenilworth, New Jersey 07033 USA. FDA revision date: 7/19/2007
Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.
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